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NCT Number: NCT00622856

The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control

A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.

All participants will be randomized into three groups:1.The first group will get a psychological treatment in order to strengthen the parent's authority. 2.The second group will get an education of a nurse and a dietician. 3.The third group will serve as a control group and will not go through an intervention.

The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of health services. 5.The costs of all psychological treatments.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center

Petah Tikva, Israel

About this study

A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.

Objectives:

  • The primary purpose of the study is to evaluate the immediate effectiveness and the long run effectiveness of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.
  • To evaluate the cost as appose to the benefit of the psychological intervention.
  • To characterize the different variables in parent's attitude that improve their children's glycemic control.
  • To develop a therapy model for strengthening parent's authority which will be suitable for parents of diabetic adolescents.

Study design:

All participants in the study will be randomized to three different groups:

  • A treatment group that will go through psychological treatment to strengthen the parents authority.
  • A control group that will get an education of a nurse and a dietician
  • A control group that will not get any intervention. All groups will include parents of diabetic adolescents with poor glycemic control.

The following data will be analyzed during the study:

  • Changes in glycemic control will be measured by levels of HbA1C.
  • Changes in the diabetes treatment by the adolescents will be measured by adherence to insulin injections, the number of times a day in which the patient checked his blood glucose values, number of visits in the clinic and psychological questionnaires.
  • Consumption of health services
  • Changes in parents attitude and changes in the wellbeing of the diabetic adolescents and their parents will be based on questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents of adolescents between the ages of 10-18
  • More than one year diabetes
  • Adolescent's HbA1c>8

Exclusion criteria

  • Adolescents or parents of adolescents that are mentally retarded.
  • Another chronic disease besides diabetes.
  • Adolescents that are taking medications that might disturb their glycemic control.

Treatment and study plan

Psychological intervention

Behavioral

Psychological intervention

Diabetes education

Behavioral

5 sessions with diabetes nurse

Primary outcomes

  1. HbA1c

    Time frame: Every three months

  2. adherence to treatment

    Time frame: before the intervention, after the intervention and at the end of the study

  3. consumption of health services

    Time frame: during the study and at the end of the study

Secondary outcomes

  1. Changes in the wellbeing of adolescents and their parents

    Time frame: In the beginning of the study, at the end of the intervention and after 6 months

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2008
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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